Miracle drug' for resistant TB to be rolled out for trial today

  • 21/03/2016

  • Times Of India (New Delhi)

A `miracle drug' to bat tle multi-drug resist ant tuberculosis MDR-TB, and extensivelydrug resistant TB (XDRTB), will be rolled out on Monday in six public hospitals across the country. This is part of a co-ordinated programme between the government and Johnson & Johnson, whose pharma arm Janssen has manufactured the drug. Named `Bedaquiline' (trade name Sirturo), the drug is perhaps the first in decades to have a potential to dramatically improve MDR-TB treatment outcomes, and reduce the number of people who die from the disease. This is probably the first instance of a multinational partnering with the government to roll out a drug, and comes as the disease spreads alarmingly . India is the world's TB epicentre as it accounts for around 23% of global cases and most deaths -220,000 in 2014 -from the bacterial lung disease that spreads through coughing and sneezing. An estimated 2.2 million people suffer from TB in India, with over 70,000 MDR-TB patients. The treatment has been rolled out under the Revised National Tuberculosis Control Programme. “We are ready with the roll-out of the drug through the government-run control programme, for which 600 patients will be enrolled across the country , over the next six to nine months, after the required tests. Upon the review of clinical data after two years, the access programme will be expanded nationwide,“ Sanjiv Navangul, Janssen India MD told TOI in an exclusive interview. “We will sit across the table (with the government) to discuss pricing. This (ther apy) is not a business (for the company) and not about rev enues, and we will be flexible about pricing,“ he added. Meanwhile, there is global concern on the pric ing of new TB drugs, includ ing Bedaquiline and Dela manid. WHO reportedly es timates the existing cost per patient for MDR-TB typical ly at $5,000-10,000, around 10 times that of treatment for TB, which burdens the al ready-struggling nationa control programmes. Janssen is believed to be offering the drug through a tiered-pricing structure, for example $3,000 in middle-in come countries and $900 in low-income countries. “Recognising the high burden of disease, India will be placed in the lowest price tier for Bedaquiline,“ Navangul said, without giv ing details about pricing. A similar programme launched in South Africa is already seeing success, the company claims. Further Janssen has entered an agree ment with Internationa Union Against Tuberculosis and Lung Diseases (Union) to conduct clinical trials, called `STREAM', to evaluate a fur ther simplified treatment re gimen. In January , Union pre sented a proposal to include Indian sites in a STREAM II study for which patients wil be enrolled.